32 research outputs found
Rebleeding rate after interventional therapy directed by capsule endoscopy in patients with obscure gastrointestinal bleeding
<p>Abstract</p> <p>Background</p> <p>The precise role of capsule endoscopy in the diagnostic algorithm of obscure gastrointestinal bleeding has yet to be determined. Despite the higher diagnostic yield of capsule endoscopy, the actual impact on clinical outcome remains poorly defined. The aim of this study was to evaluate the follow-up results of patients with obscure gastrointestinal bleeding to determine which management strategies after capsule endoscopy reduced rebleeding.</p> <p>Methods</p> <p>All patients in whom the cause of obscure gastrointestinal bleeding was investigated between May 2004 and March 2007 were studied retrospectively. We evaluated the clinical outcome of patients with obscure gastrointestinal bleeding after capsule endoscopy using the rebleeding rate as the primary outcome.</p> <p>Results</p> <p>Seventy-seven patients with obscure gastrointestinal bleeding underwent capsule endoscopy. Capsule endoscopy identified clinically significant findings that were thought to be the sources of obscure gastrointestinal bleeding in 58.4% of the patients. The overall rebleeding rate was 36.4%. The rebleeding rate was significantly higher among patients with insignificant findings than among those with significant findings (<it>p </it>= 0.036). Among the patients in whom capsule endoscopy produced significant findings, the rebleeding rate of the patients who underwent therapeutic interventions was significantly lower than that in those who did not undergo intervention (9.5% vs 40.0%, <it>p </it>= 0.046).</p> <p>Conclusion</p> <p>Follow-up and further aggressive interventions are necessary for patients with obscure gastrointestinal bleeding and significant capsule endoscopy findings to reduce the chance of rebleeding.</p
発症早期ALS患者に対する超高用量メチルコバラミンの有効性・安全性について : ランダム化比較試験
Importance:
Post hoc analysis in a phase 2/3 trial indicated ultra-high dose methylcobalamin slowed decline of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score at week 16 as well as at week 182, without increase of adverse events, in patients with amyotrophic lateral sclerosis (ALS) who were enrolled within 1 year from onset.
Objective:
To validate the efficacy and safety of ultra-high dose methylcobalamin for patients with ALS enrolled within 1 year of onset.
Design:
A multicenter, placebo-controlled, double-blind, randomized phase 3 trial with 12-week observation and 16-week randomized period, conducted from October 2017 to September 2019.
Setting:
Twenty-five neurology centers in Japan.
Participants:
Patients with ALS diagnosed within 1 year of onset by the updated Awaji criteria were initially enrolled. Of those, patients fulfilling the following criteria after 12-week observation were eligible for randomization: 1- or 2-point decrease in ALSFRS-R total score, a percent forced vital capacity over 60%, no history of noninvasive respiratory support and tracheostomy, and being ambulant. The target number was 64 in both methylcobalamin and placebo groups. Of 203 patients enrolled in the observation, 130 patients (age, 61.0 ± 11.7 years; female, 56) met the criteria and were randomly assigned through an electronic web-response system to methylcobalamin or placebo (65 for each). Of these, 129 patients were eligible for the full analysis set, and 126 completed the double-blind stage.
Interventions:
Intramuscular injection of methylcobalamin 50 mg or placebo twice weekly for 16 weeks.
Main outcomes and measures:
The primary endpoint was change in ALSFRS-R total score from baseline to week 16 in the full analysis set.
Results:
The least-squares mean difference in ALSFRS-R total score at week 16 of the randomized period was 1.97 points greater with methylcobalamin than placebo (−2.66 versus −4.63; 95% CI, 0.44–3.50; P = 0.012). The incidence of adverse events was similar between the two groups.
Conclusions and relevance:
Ultra-high dose methylcobalamin was efficacious in slowing functional decline and safe in the 16-week treatment period in ALS patients in the early stage and with moderate progression rate.
Trial registration:
UMIN-CTR Identifier: UMIN000029588 (umin.ac.jp/ctr); ClinicalTrials.gov Identifier: NCT03548311 (clinicaltrials.gov
A prospective randomized controlled multicenter trial of duodenoscopes with 5° and 15° backward-oblique angle using wire-guided cannulation : effects on selective cannulation of the common bile duct in endoscopic retrograde cholangiopancreatography
Background. In duodenoscopy, during endoscopic retrograde cholangiopancreatography (ERCP), a backward-oblique angle duodenoscope (BOAD) is generally used. In Japan, 15° BOAD are mainly used, but in Western countries, 5° BOAD are mostly used. In bile duct cannulation associated with ERCP, a catheter for contrast imaging is used in Japan, but wire-guided cannulation (WGC) using a papillotome is standard in Western countries. We conducted a randomized controlled multicenter trial to evaluate the contributions of different duodenoscopes using WGC to selective common bile duct cannulation. Methods. Subjects comprised 179 consecutive patients who underwent ERCP. Patients were randomized into the 15° BOAD group (15° group, n = 90) or the 5° BOAD group (5° group, n = 89). Results. The duodenal papilla could not be accessed endoscopically in two cases from each group. Success rates for bile duct cannulation by WGC without bow-up for the 15° and 5° groups were 85.6% and 56.2%, respectively (P < 0.01). Success rates for bile duct cannulation by WGC with bow-up for the 15° and 5° groups were 88.9% and 78.7%, respectively. Total rates of bile duct cannulation for the 15° and 5° groups were 94.4% and 92.1%, respectively. As for accidents, incidences of acute pancreatitis for the 15° and 5° groups were 5.6% and 9.0%, respectively, with no significant difference seen. Conclusions. With 15° BOAD, bile duct cannulation was favorable without papillotome bow-up. With 5° BOAD, the success rate of WGC may be improved by adjusting the angle based on papillotome bow-up
Ordered phase formation in Sm-Ni thin film deposited on Cr(100) single-crystal underlayer
Sm17Ni83 (at. %) alloy thin films are prepared on Cr(100) underlayers hetero-epitaxially grown on MgO(100) single-crystal substrates by employing an ultra-high vacuum molecular beam epitaxy system. The effect of substrate temperature on the ordered phase formation is investigated. The films deposited below 300 °C consist of amorphous phase, whereas formation of SmNi5 ordered phase is recognized for the films deposited above 400 °C. The SmNi5 films with ordered phase consist of two types of (110) variant whose c-axes are lying in the film plane and rotated around the film normal by 90° each other. With increasing the temperature from 400 to 500 °C, the long-range order degree increases from 0.65 to 0.80. The ordered film formed at 500 °C shows an in-plane magnetic anisotropy reflecting the magnetocrystalline anisotropy of SmNi5 crystal